PADLOCK CLIP-12— 510(k) K120814

Name: FDA 510(k) clearance K120814
Creator: U.S. Food and Drug Administration
Published: 2012-09-06

Substantially Equivalent

Aponos Medical Corp.

FDA 510(k) clearance K120814 for PADLOCK CLIP-12, Substantially Equivalent on 2012-09-06. Applicant: Aponos Medical Corp.. Device class: 2.

Clearance details

Applicant: Aponos Medical Corp.
Product code: Code PKL
Device class: Class 2
Regulation: 21 CFR 876.4400
Advisory panel: Gastroenterology, Urology
Date received: 2012-03-19
Decision date: 2012-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kingston, NH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PKL

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K254069 — Hemoclip (511 series, 543 series)2026-08-10
K260580 — Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR) +4 more2026-05-21
K252270 — Hemoclip2026-04-08
K253734 — Taurus Clip2026-03-12
K251562 — OTSCneo System Set (100.03n-14n, 100.27n-31n)2025-12-18

Adverse events under product code PKL

product code PKL

Death: 9
Injury: 489
Malfunction: 4,698
Other: 1
Total: 5,197

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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 K120814

K-number listed on FDA's recall record

Z-1011-2019 — US Endoscopy Padlock Clip defect closure system Ref: C910001 The Padlock Clip is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal tract, for hemostasis or for treating lesions of the wall of the gastrointestinal organs.Class II·Terminated·US Endoscopy Group Inc·20190204

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120814.

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