DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY
FDA 510(k) clearance K963715 · decided 1996-11-27
Clearance details
- K-number
- K963715
- Device name
- DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY
- Applicant
- Grand Medical Products
- Decision
- Substantially Equivalent
- Date received
- 1996-09-16
- Decision date
- 1996-11-27
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- LRO
- Device class
- 2
- Regulation number
- 878.4370
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Schaumburg, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Grand Medical Products
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
No recalls on record reference this clearance.