Hemostat
A hemostat is a surgical clamp or forceps used to control bleeding by compressing blood vessels during surgical procedures. It is classified as an FDA Class 1 device under 21 CFR 878.4800, indicating it poses minimal risk and is subject only to general controls. Product code HRQ falls under the General and Plastic Surgery medical specialty.
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Basic Information
- Product Code
- HRQ
- Device Class
- FDA class 1
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 15 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K920298 | DISPOSABLE HEMOSTATS | Aug 11, 1992 | Substantially Equivalent | Falcon Instruments, Inc. |
| K895683 | BERNARD VESSEL APPROXIMATOR | Oct 24, 1989 | Substantially Equivalent | Applied Medical Technologies |
| K890245 | SURGICAL HEMOSTATS | Jan 27, 1989 | Substantially Equivalent | Kinetic Medical Products |
| K884196 | SURGICAL INSTRUMENTS (VARIOUS TYPES & SIZES) | Nov 08, 1988 | Substantially Equivalent | Disposable Sterile Surgical Instruments, Inc. |
| K881937 | SURGICAL INSTRUMENTS | Jun 15, 1988 | Substantially Equivalent | Far East Intl. Trading Corp. |
| K861807 | MEDCARE HEMOSTATS (STRAIGHT, CURVED, MOSQUITO-TIP) | May 23, 1986 | Substantially Equivalent | Medcomp Technologies, Inc. |
| K844152 | HEMSTATS | Nov 07, 1984 | Substantially Equivalent | I M, Inc. |
| K843593 | SURGIPRESS SURGICAL LOOP | Oct 24, 1984 | Substantially Equivalent | Syntex Corp. |
| K841514 | SCANLAN VASCU-STATT II APPROXIMATOR | Jun 05, 1984 | Substantially Equivalent | Scanlan Intl., Inc. |
| K834175 | OP-CON SURG. INSTRUMENTS #11 | Jan 27, 1984 | Substantially Equivalent | Imm Enterprises , Ltd. |
| K831797 | HEMOSTATS | Jul 19, 1983 | Substantially Equivalent | I M, Inc. |
| K823694 | VASCU-STATT APPROXIMATOR | Jan 07, 1983 | Substantially Equivalent | Scanlan Intl., Inc. |
| K822263 | VARIOUS TYPES OF TONSILS HEMOSTATS | Aug 16, 1982 | Substantially Equivalent | Kelleher Corp. |
| K821887 | SCANLAN SUTURE-STATT | Jul 28, 1982 | Substantially Equivalent | Scanlan Intl., Inc. |
| K821617 | DISPOSABLE HEMOSTATS | Jun 21, 1982 | Substantially Equivalent | Medcare Products |
FEI Numbers
This FDA classification entry is associated with 182 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 182 registration numbers. Click on an entry to view related FDA registrations.