VERSAVIT— 510(k) K121675
Substantially EquivalentSynergetics, Inc.
FDA 510(k) clearance K121675 for VERSAVIT, Substantially Equivalent on 2012-06-21. Applicant: Synergetics, Inc.. Device class: 2.
Clearance details
- Applicant
- Synergetics, Inc.
- Product code
- Code HQE
- Device class
- Class 2
- Regulation
- 21 CFR 886.4150
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- O' Fallon, MO, US
Recent devices under product code HQE
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- K071482 — STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000
Adverse events under product code HQE
product code HQE- Injury
- 156
- Malfunction
- 565
- Total
- 721
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 K121675
K-number listed on FDA's recall record- Z-0119-2017 — 25 gauge VersaVit 2.0 Core Essentials Procedure Pack, Product/Part Number 70025E, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.
- Z-0120-2017 — 25 gauge VersaVit 2.0 Procedure Pack with Mid-Field Illuminator, Product/Part Number 70025S, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.
- Z-0121-2017 — 25 gauge VersaVit 2.0 Procedure Pack with Photon Wide Field Illuminator, Product/Part Number 70025SP, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.
- Z-0122-2017 — 25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935, packaged in a Tyvek/Mylar double pouch configuration.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121675.
Data sourced from openFDA. This site is unofficial and independent of the FDA.