FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DEXIDE LAPAROSCOPIC ACCESSORIES
K Number: K923845
·
Decision Nov 25, 1992
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
38
Review Days
117
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Basic Information
- Device Name
- DEXIDE LAPAROSCOPIC ACCESSORIES
- K Number
- K923845
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dexide, Inc.
- Date Received
- July 31, 1992
- Decision Date
- November 25, 1992
- Product Code
- GEI
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Dexide, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K991814 | MULTACHOICE INSTRUMENTS | Jun 23, 1999 | Substantially Equivalent |
| K990379 | MODIFICATION TO MULTAPORT CANNULA, REDUCER AND ACCESSORIES | Mar 4, 1999 | Substantially Equivalent |
| K981940 | MULTAPUMP DISPOSABLE PUMP HEAD AND ACCESSORIES | Sep 25, 1998 | Substantially Equivalent |
| K981941 | MULTAPORT CANNULA REDUCER AND ACCESSORIES | Jul 29, 1998 | Substantially Equivalent |
| K953611 | DEXIDE ENDO-LUBE KIT | Sep 15, 1995 | Substantially Equivalent |
| K944509 | DEXIDE INSUFFLATION TUBING WITH FILTER | Feb 7, 1995 | Substantially Equivalent |
| K924117 | DEXIDE LAPAROSCOPIC KITS | Mar 23, 1993 | Unknown |
| K921709 | ENDOBAG, MODIFICATION | Jul 14, 1992 | Substantially Equivalent |
| K913762 | MONOSCOPY(TM) BRAND, ENDOBAG | Oct 28, 1991 | Substantially Equivalent |
| K912637 | LAPAROSCOPIC ELECTROSURGICAL CANNULA W/RETRACTABLE | Oct 4, 1991 | Substantially Equivalent |