Product Code: MDM
FDA class 1
21 CFR 878.4800
Instrument, Manual, Surgical, General Use
General, Plastic Surgery
The general use manual surgical instrument is a hand-held general and plastic surgery device used during operative procedures for tissue manipulation, cutting, grasping, or retraction, encompassing a broad category of non-powered surgical tools. It is classified as FDA Class I under 21 CFR 878.4800 within the General and Plastic Surgery specialty, subject only to general controls. The product code is MDM and the device is not GMP-exempt. It is not implanted and does not sustain life.
510(k)s
44
FEI Numbers
840
Registration Numbers
840
Unique Applicants
37
Years Active
28
Basic Information
- Product Code
- MDM
- Device Class
- FDA class 1
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 44 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K073664 | FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER | Aug 08, 2008 | Substantially Equivalent | INJECTIMED, INC. |
| K050575 | FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM | Aug 15, 2005 | Substantially Equivalent | FUTUMEDS SDN BHD |
| K050957 | EUTROCHAR | May 18, 2005 | Substantially Equivalent | SPECIAL DEVICES, INC. |
| K023173 | ANDREWS INTRODUCER, MODEL ASI01 | Dec 18, 2002 | Substantially Equivalent | ANDREWS SURGICAL INNOVATIONS, LTD. |
| K022059 | MICROVASIVE PULMONARY GUIDEWIRE | Nov 13, 2002 | Substantially Equivalent | BOSTON SCIENTIFIC CORP. |
| K013040 | LIGHT SABER INTRODUCER NEEDLE | Dec 07, 2001 | Substantially Equivalent | MINRAD, INC. |
| K010184 | CHESS HAND SURGERY SYSTEM | Jun 22, 2001 | Substantially Equivalent | CANICA DESIGN, INC. |
| K990062 | SAPHLIFT | Mar 30, 1999 | Substantially Equivalent | GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) |
| K981579 | ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG | Jul 09, 1998 | Substantially Equivalent | ETHICON, INC. |
| K943968 | TUNNELER | Mar 01, 1995 | Substantially Equivalent | DENVER BIOMEDICALS, INC. |
| K945430 | DERMAVBLADE(TM) | Nov 28, 1994 | Substantially Equivalent | HASTING'S BIOMEDICAL CORP. |
| K941193 | EAST WEST INSTRUMENTS | Nov 09, 1994 | Substantially Equivalent | EAST WEST INSTRUMENTS, INC. |
| K941907 | APEX DISPOSABLE INSTRUMENTS | Aug 26, 1994 | Substantially Equivalent | APEX ENT., INC. |
| K942818 | DEEP SUTURE | Aug 25, 1994 | Substantially Equivalent | AUTOMATED MEDICAL PRODUCTS CORP. |
| K942896 | CLAMPS AND CLIPS | Jul 19, 1994 | Substantially Equivalent | SURGIN SURGICAL INSTRUMENTATION, INC. |
| K940684 | SURGICAL INSTRUMENT, DISPOSABLE | Mar 14, 1994 | Substantially Equivalent | HER-MAR, INC. |
| K933265 | ACU-DISPO-CE(TM) | Mar 07, 1994 | Substantially Equivalent | ACUDERM, INC. |
| K933866 | ACU-HEMOSTATIC RING | Dec 01, 1993 | Substantially Equivalent | ACUDERM, INC. |
| K925653 | DERMAPUNCH DISPOSABLE SKIN BIOPSY PUNCH | Nov 08, 1993 | Substantially Equivalent | DERMATOPATHOLOGY LABORATORY |
| K922130 | HOSPITAL KIT DK 117 | May 24, 1993 | Unknown | SAVOY MEDICAL SUPPLY CO., INC. |
| K926126 | SUTUREMATE | May 19, 1993 | Substantially Equivalent | SURGICAL SAFETY PRODUCTS, INC. |
| K930775 | DISPOSABLE FORCEPS, HEMOSTATS, NEEDLE GUIDES, ETC | Apr 23, 1993 | Substantially Equivalent | FALCON INSTRUMENTS, INC. |
| K922127 | HOSPITAL KIT GP 103 | Mar 29, 1993 | Unknown | SAVOY MEDICAL SUPPLY CO., INC. |
| K923281 | SV 100200 - SINGLE USE ONLY - STERILE HOSPITAL KIT | Mar 26, 1993 | Substantially Equivalent | SAVOY MEDICAL SUPPLY CO., INC. |
| K922128 | HOSPITAL KIT EP 104 | Mar 23, 1993 | Unknown | SAVOY MEDICAL SUPPLY CO., INC. |
| K925874 | BREAST STABILIZER | Mar 16, 1993 | Substantially Equivalent | BIP USA, INC. |
| K930399 | ORC ENDOSCOPIC INSTRUMENT HOLDER | Feb 17, 1993 | Substantially Equivalent | O.R. CONCEPTS, INC. |
| K924725 | AMERICAN BIOMED, INC. MICROSURGICAL INSTRUMENTS | Feb 05, 1993 | Substantially Equivalent | AMERICAN BIOMATERIALS CORP. |
| K924503 | PERSONNA SAFETY SCALPEL | Feb 05, 1993 | Substantially Equivalent | AMERICAN SAFETY RAZOR CO. |
| K923812 | CENTURION DISPOSABLE INSTRUMENTS | Dec 17, 1992 | Substantially Equivalent | TRI-STATE HOSPITAL SUPPLY CORP. |
| K921022 | DISPOSABLE CURETTE | Dec 03, 1992 | Substantially Equivalent | DERMTEC, INC. |
| K921988 | LACERATION REPAIR TRAY | Nov 19, 1992 | Unknown | CYPRESS MEDICAL PRODUCTS, LTD. |
| K921822 | FRAY BIO-PUNCH | Oct 28, 1992 | Substantially Equivalent | FRAY PRODUCTS CORP. |
| K922874 | DISPSABLE FORCEPS, HEMOSTATS, PROBES, NEEDLE GUIDE | Sep 11, 1992 | Substantially Equivalent | SUPRA INSTRUMENTS, INC. |
| K920297 | DISPOSABLE SCISSORS | Sep 11, 1992 | Substantially Equivalent | FALCON INSTRUMENTS, INC. |
| K920296 | DISPOSABLE FORCEPS | Sep 11, 1992 | Substantially Equivalent | FALCON INSTRUMENTS, INC. |
| K921210 | SURGICAL INSTRUMENT STAND | Apr 29, 1992 | Substantially Equivalent | MURPHY MEDICAL CENTER |
| K911369 | QUALTEX LIGHT HANDLE AND LIGHT HANDLE COVER | May 13, 1991 | Substantially Equivalent | DEROYAL INDUSTRIES, INC. |
| K911895 | QUALTEX SUTURE BOOTIES | May 08, 1991 | Substantially Equivalent | DEROYAL INDUSTRIES, INC. |
| K905105 | JAIN SUTURE/VESIBAND ORGANIZER | Jan 31, 1991 | Substantially Equivalent | JAIN SURGICAL EQUIPMENT, INC. |
| K905478 | YANKAUER SUCTION DEVICE | Dec 19, 1990 | Substantially Equivalent | MEDOVATIONS, INC. |
| K855132 | SHAVE PREP TRAY | Jan 24, 1986 | Substantially Equivalent | DYNAREX CORP. |
| K812691 | SILICONE IMPLANTS | Nov 16, 1981 | Substantially Equivalent | SUTTER BIOMEDICAL, INC. |
| K801328 | THE EQUALIZER | Jun 09, 1980 | Substantially Equivalent | THE ANSPACH EFFORT, INC. |
FEI Numbers
This FDA classification entry is associated with 840 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 840 registration numbers. Click on an entry to view related FDA registrations.