The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Insulated Electrosurgical Instruments.
| Device ID | K951986 |
| 510k Number | K951986 |
| Device Name: | INSULATED ELECTROSURGICAL INSTRUMENTS |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Renate A Maclaren |
| Correspondent | Renate A Maclaren KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-27 |
| Decision Date | 1995-06-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551102749 | K951986 | 000 |
| 04048551101193 | K951986 | 000 |
| 04048551100172 | K951986 | 000 |
| 04048551094327 | K951986 | 000 |
| 04048551094228 | K951986 | 000 |