The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Models 27040 & 27050 Conti. Flow Resectoscopes.
| Device ID | K882270 |
| 510k Number | K882270 |
| Device Name: | MODELS 27040 & 27050 CONTI. FLOW RESECTOSCOPES |
| Classification | Hysteroscope (and Accessories) |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 10111 W. JEFFERSON BLVD. Culver City, CA 90232 -3578 |
| Contact | Robert R Giorgini |
| Correspondent | Robert R Giorgini KARL STORZ ENDOSCOPY-AMERICA, INC. 10111 W. JEFFERSON BLVD. Culver City, CA 90232 -3578 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-31 |
| Decision Date | 1989-10-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551414415 | K882270 | 000 |
| 04048551414392 | K882270 | 000 |
| 04048551414378 | K882270 | 000 |
| 04048551369364 | K882270 | 000 |