The following data is part of a premarket notification filed by Renovo, Inc. with the FDA for Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves.
| Device ID | K172097 |
| 510k Number | K172097 |
| Device Name: | Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves |
| Classification | Laparoscope, General & Plastic Surgery, Reprocessed |
| Applicant | Renovo, Inc. 340 SW Columbia St. Bend, OR 97702 |
| Contact | Mark K. Wells |
| Correspondent | Robert V. Packard Medical Device Academy, Inc. 345 Lincoln Hill Rd. Shrewsbury, VT 05738 |
| Product Code | NLM |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-11 |
| Decision Date | 2017-10-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B504CB12LT0 | K172097 | 000 |
| B504B15LT0 | K172097 | 000 |
| B504B12XT9 | K172097 | 000 |
| B504B12XT0 | K172097 | 000 |
| B504B12STF9 | K172097 | 000 |
| B504B12STF0 | K172097 | 000 |
| B504B12SRT0 | K172097 | 000 |
| B504B12LTH0 | K172097 | 000 |
| B504B12LT0 | K172097 | 000 |
| B504B12LPH0 | K172097 | 000 |
| B504B12LP0 | K172097 | 000 |
| B504B11LTH0 | K172097 | 000 |
| B504B11LT0 | K172097 | 000 |
| B504B15LT9 | K172097 | 000 |
| B504B5LP0 | K172097 | 000 |
| B504B5LPH0 | K172097 | 000 |
| B504CB11LT0 | K172097 | 000 |
| B504BPT12STS9 | K172097 | 000 |
| B504BPT12STS0 | K172097 | 000 |
| B504B8LT9 | K172097 | 000 |
| B504B8LT0 | K172097 | 000 |
| B504B5XT9 | K172097 | 000 |
| B504B5XT0 | K172097 | 000 |
| B504B5ST0 | K172097 | 000 |
| B504B5SP0 | K172097 | 000 |
| B504B5SHF9 | K172097 | 000 |
| B504B5SHF0 | K172097 | 000 |
| B504B5LT0 | K172097 | 000 |
| B504B11LPH0 | K172097 | 000 |
| B504B11LP0 | K172097 | 000 |
| 00810041068910 | K172097 | 000 |
| 00810041068903 | K172097 | 000 |
| 00810041068897 | K172097 | 000 |
| 00810041068880 | K172097 | 000 |
| 00810041068873 | K172097 | 000 |
| 00810041068866 | K172097 | 000 |
| 00810041068859 | K172097 | 000 |
| 00810041068842 | K172097 | 000 |
| 00810041068835 | K172097 | 000 |
| 00810041068828 | K172097 | 000 |
| 00810041068811 | K172097 | 000 |
| 00810041068804 | K172097 | 000 |
| 00810041068927 | K172097 | 000 |
| 00810041068934 | K172097 | 000 |
| 00810041068941 | K172097 | 000 |
| 00810041069061 | K172097 | 000 |
| 00810041069054 | K172097 | 000 |
| 00810041069047 | K172097 | 000 |
| 00810041069030 | K172097 | 000 |
| 00810041069023 | K172097 | 000 |
| 00810041069016 | K172097 | 000 |
| 00810041069009 | K172097 | 000 |
| 00810041068996 | K172097 | 000 |
| 00810041068989 | K172097 | 000 |
| 00810041068972 | K172097 | 000 |
| 00810041068965 | K172097 | 000 |
| 00810041068958 | K172097 | 000 |
| 00810041068798 | K172097 | 000 |
| B504UNVCA12STS9 | K172097 | 000 |
| B504TRONB15STF0 | K172097 | 000 |
| B504TRONB15LGF0 | K172097 | 000 |
| B504TRONB12STS0 | K172097 | 000 |
| B504TRONB12STF0 | K172097 | 000 |
| B504TRONB12SHF0 | K172097 | 000 |
| B504TRONB12LGF0 | K172097 | 000 |
| B504TRONB11STF0 | K172097 | 000 |
| B504TRONB11LGF0 | K172097 | 000 |
| B504TRNONB8STF0 | K172097 | 000 |
| B504TRNONB5STF0 | K172097 | 000 |
| B504TRNONB5SHF0 | K172097 | 000 |
| B504TRNONB5LGF0 | K172097 | 000 |
| B504TRONB5LGF0 | K172097 | 000 |
| B504TRONB5SHF0 | K172097 | 000 |
| B504TRONB5STF0 | K172097 | 000 |
| B504UNVCA12STS0 | K172097 | 000 |
| B504UNVCA12STF9 | K172097 | 000 |
| B504UNVCA12STF0 | K172097 | 000 |
| B504UNVCA12LGF9 | K172097 | 000 |
| B504UNVCA12LGF0 | K172097 | 000 |
| B504TRUNVCA5STF0 | K172097 | 000 |
| B504TRUNVCA5SHF0 | K172097 | 000 |
| B504TRUNVCA5LGF0 | K172097 | 000 |
| B504TRUNVCA12STS0 | K172097 | 000 |
| B504TRUNVCA12STF0 | K172097 | 000 |
| B504TRUNVCA12LGF0 | K172097 | 000 |
| B504TRUNVCA11STF0 | K172097 | 000 |
| B504TRNONB15STF0 | K172097 | 000 |
| B504TRNONB15LGF0 | K172097 | 000 |
| B504TRB11STS0 | K172097 | 000 |
| B504TRB11STF0 | K172097 | 000 |
| B504ONB15STF9 | K172097 | 000 |
| B504ONB15STF0 | K172097 | 000 |
| B504ONB15LGF9 | K172097 | 000 |
| B504ONB15LGF0 | K172097 | 000 |
| B504D5ST0 | K172097 | 000 |
| B504D5LT0 | K172097 | 000 |
| B504D12XT0 | K172097 | 000 |
| B504D12LT0 | K172097 | 000 |
| B504D11LT0 | K172097 | 000 |
| B504CB5ST0 | K172097 | 000 |
| B504TRB12LGF0 | K172097 | 000 |
| B504TRB12LGS0 | K172097 | 000 |
| B504TRB12STF0 | K172097 | 000 |
| B504TRNONB12STS0 | K172097 | 000 |
| B504TRNONB12STF0 | K172097 | 000 |
| B504TRNONB12SHF0 | K172097 | 000 |
| B504TRNONB12LGF0 | K172097 | 000 |
| B504TRNONB11STF0 | K172097 | 000 |
| B504TRH12LP0 | K172097 | 000 |
| B504TRBPT12STS0 | K172097 | 000 |
| B504TRB5STS0 | K172097 | 000 |
| B504TRB5STF0 | K172097 | 000 |
| B504TRB5SHS0 | K172097 | 000 |
| B504TRB5SHF0 | K172097 | 000 |
| B504TRB12STS0 | K172097 | 000 |
| B504CB5LT0 | K172097 | 000 |