PENTAX Medical Auto Leakage Tester SHA-P6
FDA 510(k) clearance K212201 · decided 2021-10-01
Clearance details
- K-number
- K212201
- Device name
- PENTAX Medical Auto Leakage Tester SHA-P6
- Applicant
- Pentax of America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-07-14
- Decision date
- 2021-10-01
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- PCV
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Montvale, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Pentax of America
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 |
|---|---|---|
| AUTOMATED ENDOSCOPE LEAK TESTER (K123704) | Olympus Medical Systems Corp. | 2013-02-04 |
Recalls involving this device
No recalls on record reference this clearance.