KEVORKIAN-YOUNGE BIOPSY CURETTE #90-6611— 510(k) K802458

Clearance details

Applicant

J. Sklar Mfg. Co., Inc.

Product code

Code HFB

Device class

Class 1

Regulation

21 CFR 884.4530

Advisory panel

Obstetrics/Gynecology

Date received

1980-10-08

Decision date

1981-01-12

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mchenry, IL, US

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• K822448 — SCISSORS, VARIOUS1982-09-14
• K802457 — KEVORKIAN-YOUNGE BIOPSY PUNCH, #90-66101981-01-12

• Z-0943-2025 — 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) ECONO STERILE KEVORKIAN CURET W/O BAS STER25, Model Number 96-4145A; cervical biopsyClass II·Ongoing·Sklar Instruments·20241203

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K802458.