SAFE CONNECT SURGICAL CABLE (S-101-97/S-201-97/FL-601-97)
FDA 510(k) clearance K971968 · decided 1997-07-23
Clearance details
- K-number
- K971968
- Device name
- SAFE CONNECT SURGICAL CABLE (S-101-97/S-201-97/FL-601-97)
- Applicant
- Remington Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-05-28
- Decision date
- 1997-07-23
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- DSA
- Device class
- 2
- Regulation number
- 870.2900
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Alpharetta, GA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Remington Medical
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 |
|---|---|---|
| FAS-LOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down. Electrical extensi recall (Z-1441-2014) | Remington Medical Inc. | 2014-04-09 |
| Disposable Surgical Cable, Product Code: FL-601-97 (100), Single use, Rx Only, Remington M recall (Z-2223-2010) | Remington Medical Inc. | 2010-08-13 |