ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 114705
FDA 510(k) clearance K911272 · decided 1991-07-02
Clearance details
- K-number
- K911272
- Device name
- ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 114705
- Applicant
- Edward Weck, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-03-22
- Decision date
- 1991-07-02
- Days to decision
- 102 days
- Clearance type
- Traditional
- Product code
- FHG
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Research Triangle Pa, NC, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Edward Weck
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 |
|---|---|---|
| CIRCUMCISION KIT (K770873) | American Hospital Supply Corp. | 1977-07-11 |
Recalls involving this device
No recalls on record reference this clearance.