The following data is part of a premarket notification filed by Covidien, Formerly Us Surgical A Divison Of Tyco H with the FDA for V-loc 180 Absorbable Reload, V-loc Pbt Non-absorbable Reload, Endo Stitch (tm) Endoscopic Suturing Device, Sils (tm)....
| Device ID | K111442 |
| 510k Number | K111442 |
| Device Name: | V-LOC 180 ABSORBABLE RELOAD, V-LOC PBT NON-ABSORBABLE RELOAD, ENDO STITCH (TM) ENDOSCOPIC SUTURING DEVICE, SILS (TM)... |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H 60 Middletown Ave North Haven, CT 06473 |
| Contact | Robert Zott |
| Correspondent | Robert Zott COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H 60 Middletown Ave North Haven, CT 06473 |
| Product Code | GAM |
| Subsequent Product Code | GAT |
| Subsequent Product Code | OCW |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-24 |
| Decision Date | 2011-06-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521072654 | K111442 | 000 |
| 20884521068138 | K111442 | 000 |
| 20884521068275 | K111442 | 000 |
| 20884521068282 | K111442 | 000 |
| 20884521068787 | K111442 | 000 |
| 20884521068824 | K111442 | 000 |
| 20884521068831 | K111442 | 000 |
| 20884521073606 | K111442 | 000 |
| 20884521073774 | K111442 | 000 |
| 20884521073811 | K111442 | 000 |
| 20884521068084 | K111442 | 000 |
| 20884521068152 | K111442 | 000 |
| 20884521068114 | K111442 | 000 |
| 20884521068121 | K111442 | 000 |
| 20884521072579 | K111442 | 000 |
| 20884521072609 | K111442 | 000 |
| 20884521072616 | K111442 | 000 |
| 20884521068091 | K111442 | 000 |