ENSEAL G2 TISSUS SEALERS— 510(k) K112033
Substantially EquivalentEthicon Endo-Sugery, LLC
FDA 510(k) clearance K112033 for ENSEAL G2 TISSUS SEALERS, Substantially Equivalent on 2011-11-08. Applicant: Ethicon Endo-Sugery, LLC. Device class: 2.
Clearance details
- Applicant
- Ethicon Endo-Sugery, LLC
- Product code
- Code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cincinnati, OH, US
Recent devices under product code GEI
view allMore clearances from Ethicon Endo-Sugery, LLC
view all- K101990 — ETHICON ENDO-SURGERY GENERATOR G11, MODEL GEN11
- K110699 — LIGAMAX 5
- K091211 — EES SINGLE SITE LAPAROSCOPIC SEAL CAP ASSEMBLY W/ACCESSORIES, MODEL SSL3P, EES FIXED- LENGTH ACCESS RETRACTORS
- K082278 — MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS
- K080972 — ECHELON ZEBRA CARTRIDGES, MODELS, Z45WB, Z45BG, Z45GP, Z60WB, Z60BG, ZP60GP
Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
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 K112033
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112033.
Data sourced from openFDA. This site is unofficial and independent of the FDA.