The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Integra Jarit Video Assisted Thoracic Surgery Instruments.
| Device ID | K120012 |
| 510k Number | K120012 |
| Device Name: | INTEGRA JARIT VIDEO ASSISTED THORACIC SURGERY INSTRUMENTS |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | INTEGRA LIFESCIENCES CORPORATION 589 DAVIES DRIVE York, PA 17402 |
| Contact | Stephanie Sheesley |
| Correspondent | Stephanie Sheesley INTEGRA LIFESCIENCES CORPORATION 589 DAVIES DRIVE York, PA 17402 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-03 |
| Decision Date | 2012-09-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M2743231341 | K120012 | 000 |
| M2743238111 | K120012 | 000 |
| M274323TIP9311 | K120012 | 000 |
| M274323TIP9301 | K120012 | 000 |
| M2743239311 | K120012 | 000 |
| M2743239301 | K120012 | 000 |
| M2743239231 | K120012 | 000 |
| M2743239221 | K120012 | 000 |
| M2743239211 | K120012 | 000 |
| M2743239171 | K120012 | 000 |
| M2743238201 | K120012 | 000 |
| M2743237011 | K120012 | 000 |
| M2743231301 | K120012 | 000 |
| M274323116C1 | K120012 | 000 |
| M2743231161 | K120012 | 000 |
| M274323114A1 | K120012 | 000 |
| M274323112B1 | K120012 | 000 |
| M274323112A1 | K120012 | 000 |
| M274323110C1 | K120012 | 000 |
| M274323110B1 | K120012 | 000 |
| M2743231101 | K120012 | 000 |
| M2743239151 | K120012 | 000 |
| M2743239141 | K120012 | 000 |
| M2743239131 | K120012 | 000 |
| M274323116B1 | K120012 | 000 |
| M274323116A1 | K120012 | 000 |
| M274323114C1 | K120012 | 000 |
| M274323114B1 | K120012 | 000 |
| M2743231141 | K120012 | 000 |
| M274323112C1 | K120012 | 000 |
| M2743231121 | K120012 | 000 |
| M274323110A1 | K120012 | 000 |
| M2743237301 | K120012 | 000 |
| M2743231201 | K120012 | 000 |
| M2743231221 | K120012 | 000 |
| M2743239121 | K120012 | 000 |
| M2743239031 | K120012 | 000 |
| M2743239021 | K120012 | 000 |
| M2743239011 | K120012 | 000 |
| M2743239001 | K120012 | 000 |
| M2743231511 | K120012 | 000 |
| M2743231501 | K120012 | 000 |
| M2743231411 | K120012 | 000 |
| M2743231321 | K120012 | 000 |
| M2743237201 | K120012 | 000 |
| M2743231351 | K120012 | 000 |
| M2743234221 | K120012 | 000 |
| M2743230511 | K120012 | 000 |
| M2743230271 | K120012 | 000 |
| M2743230261 | K120012 | 000 |
| M2743230251 | K120012 | 000 |
| M2743230241 | K120012 | 000 |
| M2743230231 | K120012 | 000 |
| M2743230221 | K120012 | 000 |
| M2743230211 | K120012 | 000 |
| M2743230151 | K120012 | 000 |
| M2743230521 | K120012 | 000 |
| M2743230531 | K120012 | 000 |
| M2743234201 | K120012 | 000 |
| M2743232701 | K120012 | 000 |
| M2743232031 | K120012 | 000 |
| M2743232021 | K120012 | 000 |
| M2743230701 | K120012 | 000 |
| M2743230631 | K120012 | 000 |
| M2743230621 | K120012 | 000 |
| M2743230611 | K120012 | 000 |
| M2743230601 | K120012 | 000 |
| M2743230141 | K120012 | 000 |
| M2743230131 | K120012 | 000 |
| M2743230121 | K120012 | 000 |
| M2743231021 | K120012 | 000 |
| M2743232801 | K120012 | 000 |
| M2743238101 | K120012 | 000 |
| M2743238011 | K120012 | 000 |
| M2743238001 | K120012 | 000 |
| M2743239201 | K120012 | 000 |
| M2743239161 | K120012 | 000 |
| M2743239111 | K120012 | 000 |
| M2743239101 | K120012 | 000 |
| M2743231031 | K120012 | 000 |
| M2743231001 | K120012 | 000 |
| M2743230111 | K120012 | 000 |
| M2743236531 | K120012 | 000 |
| M2743236511 | K120012 | 000 |
| M2743236501 | K120012 | 000 |
| M2743236411 | K120012 | 000 |
| M2743236401 | K120012 | 000 |
| M2743236211 | K120012 | 000 |
| M2743236201 | K120012 | 000 |
| M2743231011 | K120012 | 000 |
| M2743231401 | K120012 | 000 |