The following data is part of a premarket notification filed by Covidien with the FDA for Reliacatch Specimen Retrieval Bag 10mm; Reliacatch Specimen Retrieval Bag 12mm.
| Device ID | K163102 |
| 510k Number | K163102 |
| Device Name: | ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen Retrieval Bag 12mm |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | COVIDIEN 60 MIDDLETON AVE. North Haven, CT 06473 |
| Contact | Katie Brown |
| Correspondent | Katie Brown COVIDIEN 60 MIDDLETON AVE. North Haven, CT 06473 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-07 |
| Decision Date | 2016-11-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521704043 | K163102 | 000 |
| 20884521704050 | K163102 | 000 |