HEM-O-LOK MODEL NUMBERS 523900, 523970
FDA 510(k) clearance K982941 · decided 1998-11-19
Clearance details
- K-number
- K982941
- Device name
- HEM-O-LOK MODEL NUMBERS 523900, 523970
- Applicant
- Weck Closure Systems
- Decision
- Substantially Equivalent
- Date received
- 1998-08-21
- Decision date
- 1998-11-19
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- FZP
- Device class
- 2
- Regulation number
- 878.4300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Research Triangle Park, NC, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Weck Closure Systems
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Hem-o-LokSMX Legating Clip, REF 544220, Lot 988384, Non-absorbable Polymer Ligation Clips, recall (Z-0547-04) | Weck | 2004-02-25 |