510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K953793Substantially Equivalent

Introscope

Polamedco, Inc., Marina Del Rey CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K953793 is the FDA 510(k) clearance record for INTROSCOPE, a class II device, cleared for Polamedco, Inc. on under FDA product code BZT (Stethoscope, Esophageal, With Electrical Conductors). FDA records list 20 510(k) clearances for Polamedco, Inc., from to . As of , FDA records show no recalls naming K953793.

Clearance record

Decision date
Received
(107 days to decision)
Product code
BZT Stethoscope, Esophageal, With Electrical Conductors
Regulation
21 CFR 868.1920
Device class
Class II
Review panel
Anesthesiology
Applicant
Polamedco, Inc. 4054 Glencoe Ave., Marina Del Rey CA
510(k) summary
Statement
Third party review
No

Clearances, product code BZT

Trailing 12 months
1 clearance under product code BZT in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code BZT, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260