Proctoscope #501
FDA 510(k) K790856 · C. Intl.
510(k) numberK790856
Submission
- Device name
- Proctoscope #501
- Applicant
- C. Intl.
Mchenry, IL, US - Received
- May 4, 1979
- Decision date
- May 29, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GCF – Proctoscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code GCF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K945209 | Proctoscopea & Accessories, Sigmoidoscopes & Accessories, Proctology InstrumentsGCF · Traditional | KARL STORZ Endoscopy-America, Inc. | 03/06/1995SE |
More from KARL STORZ Endoscopy-America, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K792494 | Catheterization ForcepGEN · Traditional | 12/20/1979SE |
| K790855 | Surgical Drape Clip #201GDO · Traditional | 08/03/1979SE |
| K790853 | Easy-SpecKNA · Traditional | 07/30/1979SE |
| K790852 | Vagi-SpecKNA · Traditional | 07/30/1979SE |
| K790851 | Vagi-Press #401KOH · Traditional | 07/30/1979SE |
| K790854 | Forceps #101 and #102GEN · Traditional | 06/05/1979SE |
Questions and answers
When was Proctoscope #501 cleared by the FDA?
Proctoscope #501 (K790856) received a 510(k) decision of Substantially Equivalent on May 29, 1979, 25 days after the submission was received.
What is the product code of K790856?
The FDA product code is GCF – Proctoscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.