KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536
FDA 510(k) clearance K072216 · decided 2007-11-09
Clearance details
- K-number
- K072216
- Device name
- KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536
- Applicant
- Kapp Surgical Instrument, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-08-09
- Decision date
- 2007-11-09
- Days to decision
- 92 days
- Clearance type
- Special
- Product code
- NEU
- Device class
- 2
- Regulation number
- 878.4300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Warrensville, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Bariatric Target Ring (Nitinol) (a thin, circular nitinol ring) Model # K-9536-N, Lot #08- recall (Z-2753-2011) | Kapp Surgical Instrument Inc | 2011-07-07 |