MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT
FDA 510(k) clearance K903878 · decided 1990-11-05
Clearance details
- K-number
- K903878
- Device name
- MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT
- Applicant
- Mentor O & O, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-08-22
- Decision date
- 1990-11-05
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- HQQ
- Device class
- 2
- Regulation number
- 886.4100
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Norwell, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Mentor O & O
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.
| Record | Firm | Date |
|---|---|---|
| SCITECH BI-MANUAL ADAPTER CLIPS (K910088) | Scitech Industries Partnership | 1991-04-08 |
| MENTOR WET-FIELD*II COAGULATOR (K881001) | Mentor O & O, Inc. | 1988-05-13 |
Recalls involving this device
No recalls on record reference this clearance.