PROCTOSCOPE #501
FDA 510(k) clearance K790856 · decided 1979-05-29
Clearance details
- K-number
- K790856
- Device name
- PROCTOSCOPE #501
- Applicant
- C. Intl.
- Decision
- Substantially Equivalent
- Date received
- 1979-05-04
- Decision date
- 1979-05-29
- Days to decision
- 25 days
- Clearance type
- Traditional
- Product code
- GCF
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch C. Intl.
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 |
|---|---|---|
| PROCTOSCOPEA & ACCESSORIES, SIGMOIDOSCOPES & ACCESSORIES, PROCTOLOGY INSTRUMENTS (K945209) | KARL STORZ Endoscopy-America, Inc. | 1995-03-06 |
Recalls involving this device
No recalls on record reference this clearance.