The following data is part of a premarket notification filed by Karl Storz Endoscopy with the FDA for Koninckx Uterine Manipulator, Keckstein-schiff Uterine Manipulator, Clermont Uterine Manipulator.
| Device ID | K992027 |
| 510k Number | K992027 |
| Device Name: | KONINCKX UTERINE MANIPULATOR, KECKSTEIN-SCHIFF UTERINE MANIPULATOR, CLERMONT UTERINE MANIPULATOR |
| Classification | Hysteroscope (and Accessories) |
| Applicant | KARL STORZ ENDOSCOPY 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Kevin A Kennan |
| Correspondent | Kevin A Kennan KARL STORZ ENDOSCOPY 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-16 |
| Decision Date | 1999-09-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551314883 | K992027 | 000 |