LAPAROSTAT(TM)
FDA 510(k) clearance K913300 · decided 1992-04-02
Clearance details
- K-number
- K913300
- Device name
- LAPAROSTAT(TM)
- Applicant
- Cook Ob/Gyn
- Decision
- Substantially Equivalent
- Date received
- 1991-07-25
- Decision date
- 1992-04-02
- Days to decision
- 252 days
- Clearance type
- Traditional
- Product code
- HAM
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Spencer, IN, 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 |
|---|---|---|
| Quiver Laparoscopic Extendable (K153472) | Itl Corporation Pty, Ltd. | 2016-06-23 |
| NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M (K000079) | Nikomed U.S.A., Inc. | 2000-02-04 |
| NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4760 (TYPICALLY) (K993306) | Paladin Medical, Inc. | 1999-11-03 |
| BERGEN 710 ESU (K945861) | Bergen Mfg. | 1995-03-01 |
| GSU HANDPIECE ADAPTER (K920100) | Beacon Laboratories, Inc. | 1992-02-03 |
| EMC MODEL NO. STATOME 900 (K911353) | Emc Industries | 1991-06-24 |
| ABC HANDPIECE ADAPTER (K901248) | Beacon Laboratories, Inc. | 1990-04-03 |
| LIGHT COAGULATOR LC 250 (K881334) | Nk-Optik GmbH | 1989-11-16 |
| ELECTROSURGICAL COAGULATION SUCTION TUBE (K895337) | New England Surgical Instrument Corp. | 1989-09-15 |
| BEAMER ONE (K894663) | Beacon Laboratories, Inc. | 1989-09-15 |
| B100 DISPOSABLE HANDPIECE (K894762) | Beacon Laboratories, Inc. | 1989-09-15 |
| #875 DISPOSABLE BIOPOLAR CABLE (K884171) | Olsen Electrosurgical, Inc. | 1988-10-24 |
Recalls involving this device
No recalls on record reference this clearance.