WOMB PREP KIT
FDA 510(k) clearance K770329 · decided 1977-04-05
Clearance details
- K-number
- K770329
- Device name
- WOMB PREP KIT
- Applicant
- American Hospital Supply Corp.
- Decision
- Substantially Equivalent
- Date received
- 1977-02-17
- Decision date
- 1977-04-05
- Days to decision
- 47 days
- Clearance type
- Traditional
- Product code
- GEN
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| NATURALASE LP ND:YAG LASER (K031828) | Focus Medical, LLC | 2003-07-17 |
| FORCEPS (K953962) | Biopsys Medical, Inc. | 1995-09-08 |
| SUTURE REMOVING FORCEPS (K932385) | Rocket of London, Ltd. | 1993-08-06 |
| FORCEPS (K904723) | Minto Research & Development, Inc. | 1991-07-26 |
| PALPATION PROBE (K911159) | Northgate Technologies, Inc. | 1991-03-29 |
| GS-1002 GRASPING FORCEP, 5MM WITH RATCHET (K900948) | Solos Endoscopy, Inc. | 1990-04-18 |
| GS-1500 CLAW FORCEP, 10MM (K900960) | Solos Endoscopy, Inc. | 1990-04-18 |
| GS-1200 GRASPING/EXTRACTING FORCEP, 10MM (K900952) | Solos Endoscopy, Inc. | 1990-04-18 |
| GS-7000 CLIP-APPLYING FORCEP, 10MM, MEDIUM CLIP (K900951) | Solos Endoscopy, Inc. | 1990-04-18 |
| TISSUE FORCEPS, VARIOUS TYPES (K891896) | Zinnanti Surgical Instruments, Inc. | 1989-04-12 |
| HEMOSTATIC FORCEPS BRUNS.,GEMINI,SPENCER-WELL,KANT (K891401) | Zinnanti Surgical Instruments, Inc. | 1989-04-06 |
| CAMPION LASER FORCEPS (K891348) | Simpson/Basye, Inc. | 1989-03-22 |
Recalls involving this device
No recalls on record reference this clearance.