The following data is part of a premarket notification filed by Genicon with the FDA for Genistrong Single-use Specimen Retrieval Bag.
| Device ID | K132375 |
| 510k Number | K132375 |
| Device Name: | GENISTRONG SINGLE-USE SPECIMEN RETRIEVAL BAG |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | GENICON 6869 STAPOINT CT., SUITE 114 Winter Park, FL 32792 |
| Contact | Katlyn Tissue |
| Correspondent | Katlyn Tissue GENICON 6869 STAPOINT CT., SUITE 114 Winter Park, FL 32792 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-30 |
| Decision Date | 2014-06-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00877972007180 | K132375 | 000 |
| 00877972006053 | K132375 | 000 |
| 00877972006077 | K132375 | 000 |
| 00877972006091 | K132375 | 000 |
| 00877972006114 | K132375 | 000 |
| 00877972006138 | K132375 | 000 |
| 00877972007081 | K132375 | 000 |
| 00877972007104 | K132375 | 000 |
| 00877972007128 | K132375 | 000 |
| 00877972007142 | K132375 | 000 |
| 00877972007166 | K132375 | 000 |
| 00877972005933 | K132375 | 000 |