SURGICAL TISSUE MANAGEMENT SYSTEM— 510(k) K111202
Substantially EquivalentOlympus Medical Systems Corp.
FDA 510(k) clearance K111202 for SURGICAL TISSUE MANAGEMENT SYSTEM, Substantially Equivalent on 2012-01-20. Applicant: Olympus Medical Systems Corp.. Device class: 2.
Clearance details
- Applicant
- Olympus Medical Systems Corp.
- 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
- Center Valley, PA, US
Recent devices under product code GEI
view allMore clearances from Olympus Medical Systems Corp.
view all- K262079 — 4K Camera Head OLYMPUS CH-S700-08-LB
- K254056 — THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS) +2 more
- K260580 — Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR) +4 more
- K252341 — EVIS EXERA III BRONCHOVIDEOSCOPE (3 models)
- K251807 — Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR
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 K111202
K-number listed on FDA's recall record- Z-1374-2026 — Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip
- Z-1375-2026 — Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip
- Z-1376-2026 — Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip
- Z-1377-2026 — Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip
- Z-1378-2026 — Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip
- Z-1379-2026 — Olympus Thunderbeat, 5 mm, 45 cm Inline Grip
- Z-1380-2026 — Olympus Thunderbeat, 5 mm, 35 cm, Inline Grip
- Z-1381-2026 — Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip
- Z-1382-2026 — Olympus Thunderbeat 5 mm, 10 cm, Inline Grip
- Z-0432-2014 — TB-0545PC: THUNDERBEAT 5 mm , 45 em, Pistol Grip TB-0535PC: THUNDERBEAT 5 mm, 35 em, Pi stol Grip TB-0545IC: THUNDERBEAT 5 mm, 45 em, In line Grip TB-0535IC: THUNDERBEAT 5 mm, 35 em, Inline Grip TB-0520IC: THUNDERBEAT 5 mm, 20 em, In line Grip TB-051 OIC: THUNDERBEAT 5 mm, I 0 em, In line Grip TB-545FC: THUNDERBEAT 5 mm, 45 em, Front Actuated Grip TB-0535FC: THUNDERBEAT 5 mm, 35 em, Front Actuated Grip The Olympus Thunderbeat Surgical Tissue Management System ("Thunderbeat") is intended to be used for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111202.
Data sourced from openFDA. This site is unofficial and independent of the FDA.