Company
Sklar Instruments
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
30recalls (0 in 12 months)
6recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EPY | Speculum, Ent | 1 |
| FBX | Sound, Urethral, Metal Or Plastic | 1 |
| FFO | Retractor, Self-Retaining | 1 |
| FZS | Curette, Surgical, General Use | 1 |
| FZT | Cutter, Surgical | 1 |
| GAD | Retractor | 1 |
| GAF | Spatula, Surgical, General & Plastic Surgery | 1 |
| GDG | Hook, Surgical, General & Plastic Surgery | 1 |
| GDJ | Clamp, Surgical, General & Plastic Surgery | 1 |
| GDZ | Handle, Scalpel | 1 |
| GEA | Cannula, Surgical, General & Plastic Surgery | 1 |
| GEN | Forceps, General & Plastic Surgery | 1 |
| HCY | Curette, Uterine | 1 |
| HDF | Speculum, Vaginal, Metal | 1 |
| HDL | Retractor, Vaginal | 1 |
| HDQ | Dilator, Cervical, Fixed Size | 1 |
| HFB | Forceps, Biopsy, Gynecological | 1 |
| HHF | Remover, Intrauterine Device, Contraceptive, Hook-Type | 1 |
| HNC | Specula, Ophthalmic | 1 |
| HNF | Scissors, Ophthalmic | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 16, 2025 | Sklar Instruments ECONO STERILE medical procedure kits labeled as:
1) ECONO STERILE OLSEN-HEG NH SMO DEL 5.5STER25, Model Number 96-2352A;
2) ECONO STERILE HALSEY NH SERR 5" STRL CS/25, Model Number 96-2353;
3) E Open, Classified |
HXK | None listed |
| Jan 16, 2025 | Sklar Instruments ECONO STERILE medical procedure kits labeled as:
1) ECONO STERILE PROBE W/EYE CS/50, Model Number 94-5923;
2) ECONO STERIL" PROBE W/EYE 5.5" STERL CS/25, Model Number 96-2361; orthopedic probe Open, Classified |
HXB | None listed |
| Jan 16, 2025 | Sklar Instruments ECONO STERILE medical procedure kits labeled as:
ECONO STERILE LEMPERT BONE RONG 6.25" STER25, Model Number 96-4780A; orthopedic surgery Open, Classified |
HTX | None listed |
| Jan 16, 2025 | Sklar Instruments ECONO STERILE medical procedure kits labeled as:
ECONO STERILE IRIS HOOK QK REL 4MM 9" STER25, Model Number 96-2224A; eye surgery Open, Classified |
HNQ | None listed |
| Jan 16, 2025 | Sklar Instruments Medical procedure kits labeled as:
1) ECONO STERILE STRABIS SCISS STR 4.5"STER 50, Model Number 96-2540;
2) ECONO STERILE STRABIS SCISS CVD 4.5"STER 50, Model Number 96-2541;
3) ECONO STERILE STRA Open, Classified |
HNF | None listed |
| Jan 16, 2025 | Sklar Instruments ECONO STERILE medical procedure kits labeled as:
ECONO STERILE ALFONSO INFANT SPEC STRL CS/10, Model Number 96-3814; eyelid surgery Open, Classified |
HNC | None listed |
| Jan 16, 2025 | Sklar Instruments ECONO STERILE medical procedure kits labeled as:
ECONO STERILE IUD EXTRACTOR DBL HK 10.5"CS25, Model Number 96-4146A Open, Classified |
HHF | K772229 |
| Jan 16, 2025 | Sklar Instruments ECONO STERILE medical procedure kits labeled as:
1) ECONO STERILE MINI TISCH 2.3X4.2MM STER CS10, Model Number 96-4134M;
2) ECONO STERILE OVAL BIOPSY FCP 3X7MM STER10, Model Number 96-4137M; gynec Open, Classified |
HFB | K772229 |
| Jan 16, 2025 | Sklar Instruments ECONO STERILE medical procedure kits labeled as:
1) ECONO STERILE HEGAR DILATOR 11&12MM STRLCS25Model Number 96-0960;
2) ECONO STERILE HEGAR DILATOR 9&10MM STRL CS25Model Number 96-0961;
3) ECONO Open, Classified |
HDQ | K772229 |
| Jan 16, 2025 | Sklar Instruments ECONO STERILE medical procedure kits labeled as:
ECONO STERILE KOGAN ENDOCERV SPEC STER CS/5, Model Number 96-4142A, gynecological procedures Open, Classified |
HDL | None listed |
| Jan 16, 2025 | Sklar Instruments ECONO STERILE medical procedure kits labeled as:
1) ECONO STERILE GRAVES SPEC STRL SM BX/25, Model Number 96-2603;
2) ECONO STERILE GRAVES SPEC STRL MD BX/25, Model Number 96-2605;
3) ECONO STER Open, Classified |
HDF | None listed |
| Jan 16, 2025 | Sklar Instruments ECONO STERILE medical procedure kits labeled as:
1) ECONO STERILE SIMS UTERINE CURETTE #3 STER25, Model Number 96-4113;
2) ECONO STERILE KEVORK ENDO CURET W/BAS STER25, Model Number 96-4144A;
3) E Open, Classified |
HCY | K772229 K802458 |
| Jan 16, 2025 | Sklar Instruments ECONO STERILE medical procedure kits labeled as:
ECONO STERILE SCHAMBERG EXTRCT SQ STER CS25, Model Number 96-2395M; blackhead extractor Open, Classified |
MDM | None listed |
| Jan 16, 2025 | Sklar Instruments ECONO STERILE medical procedure kits labeled as:
1) ECONO STERILE IRIS SCISS 4 1/2" CVD CASE/50,Model Number 941-0918;
2) ECONO STERILE METZENBAUM SCIS STR 9"STER C25,Model Number 941-1556;
3) ECO Open, Classified |
LRW | None listed |
| Jan 16, 2025 | Sklar Instruments ECONO STERILE medical procedure kits labeled as:
ECONO STERILE BLAKE GALLSTONE FCP CVD 8"CS25, Model Number 96-4921A Open, Classified |
HTD | K012660 |
| Jan 16, 2025 | Sklar Instruments ECONO STERILE medical procedure kits labeled as:
1) ECONO STERILE ROCH-PEAN FCP 8" CVD CS/25,Model Number 94-0286;
2) ECONO STERILE DRESSING FCP 5.5" CS/25LG,Model Number 94-0290;
3) ECONO STERIL Open, Classified |
GEN | K772229 K801273 |
| Jan 16, 2025 | Sklar Instruments ECONO STERILE medical procedure kits labeled as:
1) ECONO STERILE YANKAUER SUCTION TUBE 8.5" C10, Model Number 96-4176;
2) ECONO STERILE YANKAUER SUCTION TUBE 11" CS10, Model Number 96-4177;
3) EC Open, Classified |
GEA | None listed |
| Jan 16, 2025 | Sklar Instruments ECONO STERILE medical procedure kits labeled as:
ECONO STERILE SCALPEL HDL #3 W/METRIC CS/25, Model Number 96-3500M Open, Classified |
GDZ | None listed |
| Jan 16, 2025 | Sklar Instruments ECONO STERILE medical procedure kits labeled as:
1) ECONO STERILE BACKHAUS TWL CLP STER 3.5 CS50, Model Number 96-2630;
2) ECONO STERILE BACKHAUS TWL CLP STER 5.25 25, Model Number 96-2636; general Open, Classified |
GDJ | None listed |
| Jan 16, 2025 | Sklar Instruments ECONO STERILE medical procedure kits labeled as:
1) ECONO STERILE VEIN HOOK 1.5MM STERILE CS/25, Model Number 96-4020M;
2) ECONO STERILE VEIN HOOK 2MM STERILE CS/25, Model Number 96-4021M;
3) ECON Open, Classified |
GDG | None listed |
| Jan 16, 2025 | Sklar Instruments ECONO STERILE medical procedure kits labeled as:
ECONO STERILE CEMENT SPATULA #24 STRL CS/25, Model Number 96-2245M, mixing utensil, dental Open, Classified |
GAF | None listed |
| Jan 16, 2025 | Sklar Instruments ECONO STERILE medical procedure kits labeled as:
1) ECONO STERILE ARMY RETR (SET OF 2) STER CS25, Model Number 96-2243;
2) ECONO STERILE ARMY RETR (SET OF 2)STRL CS/25, Model Number 96-2243M;
3) E Open, Classified |
GAD | None listed |
| Jan 16, 2025 | Sklar Instruments ECONO STERILE medical procedure kits labeled as:
1) ECONO STERILE D/A NAIL NIPPER 5.75" STER CS5, Model Number 96-2424A;
2) ECONO STERILE TISS NIPPER 14MM CVX 5"CS/25, Model Number 96-2427;
3) ECO Open, Classified |
FZT | None listed |
| Jan 16, 2025 | Sklar Instruments ECONO STERILE medical procedure kits labeled as:
ECONO STERILE" CURETTE EXCAVATOR STRL CS/25, Model Number 941-1320; general surgical Open, Classified |
FZS | None listed |
| Jan 16, 2025 | Sklar Instruments ECONO STERILE medical procedure kits labeled as:
1) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2236;
2) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2237M;
3) ECO Open, Classified |
EPY | None listed |
| Jan 16, 2025 | Sklar Instruments ECONO STERILE medical procedure kits labeled as:
1) ECONO STERILE WEITLANER RETR SH 2X3 4.5"CS25, Model Numbers: 96-2201A;
2) ECONO STERILE WEITLANER RETR BL 2X3 4.5"CS25, Model Numbers: 96-2203A Open, Classified |
FFO | None listed |
| Jan 16, 2025 | Sklar Instruments ECONO STERILE medical procedure kits labeled as:
ECONO STERILE SIMS UTERINE SND GRD 13"STER25, Model Numbers: 96-2478 (gynecological use) Open, Classified |
FBX | None listed |
| Jan 16, 2025 | Sklar Instruments ECONO STERILE medical procedure kits labeled as:
ECONO STERILE TROUSSEAU DILATOR CS/25, Model Number 941-0191 (tracheal procedures) Open, Classified |
KCG | None listed |
| Jan 16, 2025 | Sklar Instruments ECONO STERILE brand medical procedure kits labeled as:
1) ECONO STERILE FREER ELEV DE S/B 7.25" CS/25, Model Number 96-2483 (multiple purpose);
2) ECONO STERILE LOCKE ELEV #94 NARROW STER 25, Mode Open, Classified |
KAD | None listed |
| Jan 16, 2025 | Sklar Instruments ECONO STERILE brand medical procedure kits labeled as:
1) ECONO STERILE" BUCK EAR CUR BL STR#0STRLCS/25, Model Number 96-2273;
2) ECONO STERILE" BILLEAU EAR LOOP MD STRL CS/25, Model Number 96-228 Open, Classified |
JYG | None listed |