510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K092827Substantially Equivalent

Dimela Obsterical Forceps, Model 72.1 Xx Xx

Dimeda Instrumente GmbH, Tuttlingen, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K092827 is the FDA 510(k) clearance record for DIMELA OBSTERICAL FORCEPS, MODEL 72.1 XX XX, a class II device, cleared for Dimeda Instrumente GmbH on under FDA product code HDA (Forceps, Obstetrical). FDA records list one 510(k) clearance for Dimeda Instrumente GmbH. As of , FDA records show no recalls naming K092827.

Clearance record

Decision date
Received
(116 days to decision)
Product code
HDA Forceps, Obstetrical
Regulation
21 CFR 884.4400
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Dimeda Instrumente GmbH Schwarzwaldstrabe 5, Tuttlingen, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HDA

Trailing 12 months

FDA records hold no clearances under product code HDA in the trailing twelve months.

FDA records show no clearances under product code HDA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HDA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260