HULKA CLIP FOR TUBAL OCCLUSION
FDA premarket approval P870080/S002 · decided 2016-10-14
Approval details
- PMA number
- P870080
- Supplement
- S002
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HULKA CLIP FOR TUBAL OCCLUSION
- Generic name
- Laparoscopic contraceptive tubal occlusion device
- Applicant
- Richard Wolf Medical Instruments Corp.
- Date received
- 2016-08-22
- Decision date
- 2016-10-14
- Days to decision
- 53 days
- Decision code
- OK30
- Product code
- KNH
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Vernon Hills, IL
- Statement
- Manufacturing process change involving the replacement of a manual cleaning process with an ultrasonic cleaning process.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| core nova Complete Operating Room Endoscopy (K151282) | Richard Wolf Medical Instruments Corp. | 2016-01-12 |
| THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525 (K130423) | Richard Wolf Medical Instruments Corp. | 2013-04-03 |
| ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2 (K121724) | Richard Wolf Medical Instruments Corp. | 2012-09-20 |
| KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CA (K120898) | Richard Wolf Medical Instruments Corp. | 2012-08-03 |
| MEGAPULSE LASER SYSTEM AND FIBERS (K090776) | Richard Wolf Medical Instruments Corp. | 2009-06-02 |
| POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES (K080617) | Richard Wolf Medical Instruments Corp. | 2008-06-27 |
| 3 CCD ENDOCAM 5550 (K080977) | Richard Wolf Medical Instruments Corp. | 2008-05-14 |
| VIEW MD OFFICE SYSTEM, MODEL 41066.5540 (K071292) | Richard Wolf Medical Instruments Corp. | 2007-07-19 |