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
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 ↗

Recent devices under product code GCJ

view all

More clearances from Aesculap, Inc.

view all

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.