510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K991592Substantially Equivalent

Ksea De La Plaza Blepharoplasty Set

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

K991592 is the FDA 510(k) clearance record for KSEA DE LA PLAZA BLEPHAROPLASTY SET, a class I device, cleared for KARL STORZ Endoscopy-America, Inc. on under FDA product code HNI (Retractor, Ophthalmic). FDA records list 402 510(k) clearances for KARL STORZ Endoscopy-America, Inc., from to . As of , FDA records show no recalls naming K991592.

Clearance record

Decision date
Received
(179 days to decision)
Product code
HNI Retractor, Ophthalmic
Regulation
21 CFR 886.4350
Device class
Class I
Review panel
Ophthalmic
Applicant
KARL STORZ Endoscopy-America, Inc. 600 Corporate Pt.e, Culver City CA
510(k) summary
Summary
Third party review
No

Clearances, product code HNI

Trailing 12 months

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

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