COAGULATOR CUTTER, ENDOSCOPIC BIPOLAR AND ACCESSORIES
FDA 510(k) clearance K943776 · decided 1994-11-03
Clearance details
- K-number
- K943776
- Device name
- COAGULATOR CUTTER, ENDOSCOPIC BIPOLAR AND ACCESSORIES
- Applicant
- Richard Wolf Medical Instruments Corp.
- Decision
- Substantially Equivalent
- Date received
- 1994-08-02
- Decision date
- 1994-11-03
- Days to decision
- 93 days
- Clearance type
- Traditional
- Product code
- HIN
- Device class
- 2
- Regulation number
- 884.4150
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Vernon Hills, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Richard Wolf Medical Instruments Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PK Lap Loop (K142525) | Olympus Winter & Ibe GmbH | 2014-11-21 |
| LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE (K130305) | Lina Medical Aps | 2013-07-24 |
| KSEA BIPOLAR ELECTRODE (K122983) | KARL STORZ Endoscopy-America, Inc. | 2013-06-26 |
| PKS BILL (K122605) | Gyrus Acmi, Inc. | 2012-12-05 |
| TUBALGATOR (K113080) | Mectra Labs, Inc. | 2012-06-29 |
| VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS (K111751) | ETHICON, Inc. | 2011-12-02 |
| GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL) (K111059) | Gyrus Acmi, Inc. | 2011-09-01 |
| BIPOLAR FORCEPS, KLEPPINGER INSERT, MODEL #'S 8393.741,8393.771,8394.741,8394.771 (K990147) | Richard Wolf Medical Instruments Corp. | 1999-04-16 |
| BICOAG COAGULATING FORCEPS (K971565) | Everest Medical Corp. | 1998-03-12 |
| ELMED LBC 50-P (K926517) | Elmed, Inc. | 1994-11-15 |
| STI TISSUE MANIPULATOR (K911699) | Surgical Technologies, Inc. | 1991-06-13 |
| MODEL 26021C BIPOLAR COAGULATOR (K871745) | KARL STORZ Endoscopy-America, Inc. | 1987-07-10 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| HULKA CLIP FOR TUBAL OCCLUSION (P870080/S002) | Richard Wolf Medical Instruments Corp. | 2016-10-14 |
| HULKA CLIP FOR TUBAL OCCLUSION (P870080/S001) | Richard Wolf Medical Instruments Corp. | 1998-03-12 |
| HULKA CLIP FOR TUBAL OCCLUSION (P870080) | Richard Wolf Medical Instruments Corp. | 1996-09-05 |
| RICHARD WOLF PIEZOLITH E.L.P. LITHOTRIPT MODEL2300 (P890013) | Richard Wolf Medical Instruments Corp. | 1991-09-09 |