O.R. CONCEPTS' IRRIGATING KITTNER
FDA 510(k) clearance K923818 · decided 1993-04-07
Clearance details
- K-number
- K923818
- Device name
- O.R. CONCEPTS' IRRIGATING KITTNER
- Applicant
- O.R. Concepts, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-07-30
- Decision date
- 1993-04-07
- Days to decision
- 251 days
- Clearance type
- Traditional
- Product code
- FGS
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Roanoke, TX, 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 |
|---|---|---|
| QB II BLUNT DISSECTOR (K933604) | Joyce M. Shotwell, M.D. | 1993-09-23 |
| ENDOSCOPIC BLUNT DISSECTING INSTRUMENT (K931854) | Mayaguez Medical Center | 1993-08-10 |
| ENDOSCOPIC SPONGE CARRIER (K822194) | Kelleher Corp. | 1982-08-27 |
Recalls involving this device
No recalls on record reference this clearance.