The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Interceptre Laparoscopic Instruments.
| Device ID | K970151 |
| 510k Number | K970151 |
| Device Name: | INTERCEPTRE LAPAROSCOPIC INSTRUMENTS |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | SMITH & NEPHEW, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Contact | Susan A Finneran |
| Correspondent | Susan A Finneran SMITH & NEPHEW, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-15 |
| Decision Date | 1997-03-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556609804 | K970151 | 000 |
| 03596010380944 | K970151 | 000 |
| 03596010380920 | K970151 | 000 |
| 03596010380913 | K970151 | 000 |
| 03596010380906 | K970151 | 000 |
| 03596010380890 | K970151 | 000 |
| 03596010515827 | K970151 | 000 |
| 03596010507358 | K970151 | 000 |
| 03596010380937 | K970151 | 000 |
| 03596010475459 | K970151 | 000 |
| 03596010475466 | K970151 | 000 |
| 00885556609453 | K970151 | 000 |
| 00885556609422 | K970151 | 000 |
| 00885556607947 | K970151 | 000 |
| 00885556607930 | K970151 | 000 |
| 00885556602997 | K970151 | 000 |
| 00885556602980 | K970151 | 000 |
| 03596010380951 | K970151 | 000 |
| 03596010478627 | K970151 | 000 |
| 03596010475350 | K970151 | 000 |