The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Endopath Endoscopic Tissue Fastening System With Coated Vicryl, Models Sw210, Sw220, Sw220,sw230, Sw212, Sw222 And Sw232.
| Device ID | K992612 |
| 510k Number | K992612 |
| Device Name: | ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM WITH COATED VICRYL, MODELS SW210, SW220, SW220,SW230, SW212, SW222 AND SW232 |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | Edwin O Billips |
| Correspondent | Edwin O Billips ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-04 |
| Decision Date | 1999-10-14 |
| Summary: | summary |