The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Proctoscopea & Accessories, Sigmoidoscopes & Accessories, Proctology Instruments.
| Device ID | K945209 |
| 510k Number | K945209 |
| Device Name: | PROCTOSCOPEA & ACCESSORIES, SIGMOIDOSCOPES & ACCESSORIES, PROCTOLOGY INSTRUMENTS |
| Classification | Proctoscope |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Judith K Murphy |
| Correspondent | Judith K Murphy KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | GCF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-25 |
| Decision Date | 1995-03-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551405604 | K945209 | 000 |
| 04048551228869 | K945209 | 000 |
| 04048551085080 | K945209 | 000 |
| 04048551084724 | K945209 | 000 |
| 04048551083802 | K945209 | 000 |
| 04048551083703 | K945209 | 000 |
| 04048551085028 | K945209 | 000 |
| 04048551084373 | K945209 | 000 |
| 04048551083765 | K945209 | 000 |