LIGAMAX 5— 510(k) K110699
Substantially EquivalentEthicon Endo-Sugery, LLC
FDA 510(k) clearance K110699 for LIGAMAX 5, Substantially Equivalent on 2011-03-25. Applicant: Ethicon Endo-Sugery, LLC. Device class: 2.
Clearance details
- Applicant
- Ethicon Endo-Sugery, LLC
- Product code
- Code FZP
- Device class
- Class 2
- Regulation
- 21 CFR 878.4300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cincinnati, OH, US
Recent devices under product code FZP
view allMore clearances from Ethicon Endo-Sugery, LLC
view all- K112033 — ENSEAL G2 TISSUS SEALERS
- K101990 — ETHICON ENDO-SURGERY GENERATOR G11, MODEL GEN11
- 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 FZP
product code FZP- Death
- 11
- Injury
- 726
- Malfunction
- 10,830
- Other
- 1
- Total
- 11,568
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 K110699
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 K110699.
Data sourced from openFDA. This site is unofficial and independent of the FDA.