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