DeviceClearance

HYBRID TROCAR SYSTEM— 510(k) K101937

Substantially Equivalent

Aesculap, Inc.

FDA 510(k) clearance K101937 for HYBRID TROCAR SYSTEM, Substantially Equivalent on 2010-08-11. Applicant: Aesculap, Inc.. Device class: 2.

Clearance details

Applicant
Aesculap, Inc.
Product code
Product code GCJ
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Center Valley, PA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code GCJ

product code GCJ
Death
39
Injury
1,638
Malfunction
28,216
Other
11
Total
29,904

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K101937

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K101937.

Data sourced from openFDA. This site is unofficial and independent of the FDA.