510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K954982Substantially Equivalent

Ksea Scalp Blood Collection Set

Karl Storz Endoscopy-America, Inc., Culver City CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954982 is the FDA 510(k) clearance record for KSEA SCALP BLOOD COLLECTION SET, a class II device, cleared for KARL STORZ Endoscopy-America, Inc. on under FDA product code HGK (Endoscope, Fetal Blood Sampling (And Accessories)). FDA records list 402 510(k) clearances for KARL STORZ Endoscopy-America, Inc., from to . As of , FDA records show no recalls naming K954982.

Clearance record

Decision date
Received
(260 days to decision)
Product code
HGK Endoscope, Fetal Blood Sampling (And Accessories)
Regulation
21 CFR 884.1660
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
KARL STORZ Endoscopy-America, Inc. 600 Corporate Pt.e, Culver City CA
510(k) summary
Summary
Third party review
No

Clearances, product code HGK

Trailing 12 months

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

FDA records show no clearances under product code HGK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HGK, 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