Decision Date2012-01-20
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
SURGICAL TISSUE MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2012-01-20 under 510(k) number K111202. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SURGICAL TISSUE MANAGEMENT SYSTEM?
SURGICAL TISSUE MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2012-01-20. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K111202.
When did SURGICAL TISSUE MANAGEMENT SYSTEM receive FDA 510(k) clearance?
SURGICAL TISSUE MANAGEMENT SYSTEM received FDA 510(k) clearance on 2012-01-20, under 510(k) number K111202.
Who is the listed applicant for SURGICAL TISSUE MANAGEMENT SYSTEM?
The FDA 510(k) record lists Olympus Medical Systems Corp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SURGICAL TISSUE MANAGEMENT SYSTEM?
The FDA product code for SURGICAL TISSUE MANAGEMENT SYSTEM is GEI.
Related Clinical Trials
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Other records listing Olympus Medical Systems Corp. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
K2620794K Camera Head OLYMPUS CH-S700-08-LBK254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)K260580Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)K252341EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)K251807Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LRK253646Single Use Distal Cover MAJ-2315 (MAJ-2315) View all 97 devices →
Related Devices (Code: GEI)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)Stryker InstrumentsK254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLCK261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLCK254185Potenza PrimeJeisys Medical IncorporatedK262364Ellian Enigma RF DeviceEllian CorpK253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.