The following data is part of a premarket notification filed by Sterling Medical Inc with the FDA for H/s Catheter Set 5 French, Model 61-5005f, H/s Catheter Set 7 French, Model 61-5007f.
| Device ID | K092969 |
| 510k Number | K092969 |
| Device Name: | H/S CATHETER SET 5 FRENCH, MODEL 61-5005F, H/S CATHETER SET 7 FRENCH, MODEL 61-5007F |
| Classification | Cannula, Manipulator/injector, Uterine |
| Applicant | STERLING MEDICAL INC 683 NORTH SPENCE AVE Goldsboro, NC 27534 |
| Contact | Thomas Trimnal |
| Correspondent | Thomas Trimnal STERLING MEDICAL INC 683 NORTH SPENCE AVE Goldsboro, NC 27534 |
| Product Code | LKF |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-25 |
| Decision Date | 2010-04-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850011427217 | K092969 | 000 |
| B296061050 | K092969 | 000 |
| B29606105F0 | K092969 | 000 |
| B29606105F10 | K092969 | 000 |
| B29606105F400 | K092969 | 000 |
| B29606105X0 | K092969 | 000 |
| B29606105X10 | K092969 | 000 |
| B29606105X400 | K092969 | 000 |
| B296061070 | K092969 | 000 |
| B29606107F0 | K092969 | 000 |
| B29606107F10 | K092969 | 000 |
| B29606107F400 | K092969 | 000 |
| B29606107X0 | K092969 | 000 |
| B2906105X30 | K092969 | 000 |
| 00850011427125 | K092969 | 000 |
| 00850011427194 | K092969 | 000 |
| 10850011427146 | K092969 | 000 |
| 10850011427153 | K092969 | 000 |
| B296063000 | K092969 | 000 |
| B296063001 | K092969 | 000 |
| B296063051 | K092969 | 000 |
| B296063071 | K092969 | 000 |
| 00850011427071 | K092969 | 000 |
| 00850011427088 | K092969 | 000 |
| 00850011427095 | K092969 | 000 |
| 00850011427101 | K092969 | 000 |
| 00850011427118 | K092969 | 000 |
| B29606107X10 | K092969 | 000 |
| B29606107X400 | K092969 | 000 |
| B296062050 | K092969 | 000 |
| B296C050505 | K092969 | 000 |
| B296C0620508 | K092969 | 000 |
| B296C0700FIRM0 | K092969 | 000 |
| B296C0700FR01 | K092969 | 000 |
| B296C070709 | K092969 | 000 |
| B296E0500FIRM0 | K092969 | 000 |
| B296E0500FR01 | K092969 | 000 |
| B296E050507 | K092969 | 000 |
| B296E062050 | K092969 | 000 |
| B296E0700FIRM00 | K092969 | 000 |
| B296E0700FR03 | K092969 | 000 |
| B296E07070 | K092969 | 000 |
| B296C0500FR0 | K092969 | 000 |
| B296C0500FIRM0 | K092969 | 000 |
| B296063050 | K092969 | 000 |
| B296063070 | K092969 | 000 |
| B29661500500 | K092969 | 000 |
| B296615005101 | K092969 | 000 |
| B29661500702 | K092969 | 000 |
| B296615007103 | K092969 | 000 |
| B296B0500FIRM0 | K092969 | 000 |
| B296B0500FR0 | K092969 | 000 |
| B296B05050 | K092969 | 000 |
| B296B0700FIRM0 | K092969 | 000 |
| B296B0700FR00 | K092969 | 000 |
| B296B070708 | K092969 | 000 |
| B296M03560 | K092969 | 000 |