510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Origin Medsystems, Inc.

San Mateo, CA, US

Origin Medsystems, Inc. appears in FDA device records in San Mateo, CA. FDA records list 50 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
50
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 50 510(k) clearances for Origin Medsystems, Inc. between 1989 and 1999. The busiest year on record is 1994, with 12. The most recent is 1999, with 1.

Clearances by year, as a table
510(k) clearance decisions for Origin Medsystems, Inc., by decision year
YearClearances
19891
19903
19914
19925
19939
199412
19955
19965
19974
19981
19991
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K992353BLUNT TIP TROCAR PORTGCJSubstantially Equivalent
K981700VASOVIEW DISSECTION/VESSEL HARVESTING SYSTEMGCJSubstantially Equivalent
K972685ORIGIN LIGATOR DEVICEGCJSubstantially Equivalent
K970611ORIGIN CARDIAC STABLIZER OCCLUDERDXCSubstantially Equivalent
K965121CANNULAHETSubstantially Equivalent
K964171VASOVIEW BALLOON DISSECTION SYSTEMGCJSubstantially Equivalent
K962104AIRLIFT BALLOON RETRACTON SYSTEMGCJSubstantially Equivalent
K962005EXTRAHAND BALLOON RETRACTORGCJSubstantially Equivalent
K960936RESPOSABLE TROCAR SYSTEM [5MM, 5MM SHORT, 10MM AND 12MM SIZES]HETSubstantially Equivalent
K9606375MM ENDOSCOPEGCJSubstantially Equivalent
K955163DISSECTION PROBEGEISubstantially Equivalent
K954175DUO BALLOON SYSTEM (DBS) 1[10 AND 12 MM SIZES]GCJSubstantially Equivalent
K954174DUO BALLOON SYSTEM (DBS) 2 [10 AND 12 MM SIZES]GCJSubstantially Equivalent
K953377DISTENTION BALLOONGCJSubstantially Equivalent
K953561PREPERITONEAL DISTENTION BALLOON SYSTEMS (MODIFICATION)GCJSubstantially Equivalent
K946002ORIGIN PREPERITONEAL DISSECTION BALLOON SYSTEM (PDBS)--EXTRAGEXSubstantially Equivalent
K944415ORIGIN TACKER SYSTEMOCWSubstantially Equivalent
K945023ORIGIN PIXIE STIC INTRODUCER SLEEVEGCJSubstantially Equivalent
K944304ORIGIN BALLOON ANCHORGCJSubstantially Equivalent
K942678LIFTING DISTENTION BALLOON SYSTEMGCJSubstantially Equivalent
K942491ORIGIN BALLOON RETRACTORGCJSubstantially Equivalent
K942636PSB PREPERITONEAL STRUCTURE BALLOONGCJSubstantially Equivalent
K940875ADJUSTABLE BALLOON DISSECTION CANNULAGCJSubstantially Equivalent
K930813PISTOL SUCTION/IRRIGATION PROBEGCJSubstantially Equivalent
K930848SENSING TIP SURGICAL TROCARGCJSubstantially Equivalent
K933075LAPAROSCOPIC RETRACTORGCJSubstantially Equivalent
K931522FASCIAL CLOSURE DEVICEGCJSubstantially Equivalent
K935426PREPERITONEAL DISTENTION BALLOON SYSTEMGCJSubstantially Equivalent
K933724SENSOR-TIP TROCARGCJSubstantially Equivalent
K933106ENDOSCOPEODFSubstantially Equivalent
K926480LAPAROSCOPIC BALLOON RETRACTORGCJSubstantially Equivalent
K934134DISTENTION INSTRUMENT, MODIFICATIONGCJSubstantially Equivalent
K921103RETRACTION INSTRUMENTGCJSubstantially Equivalent
K932229SURGICAL TROCAR AND TROCAR SLEEVEGCJSubstantially Equivalent
K930301TROCAR SHEATH ANCHORGCJSubstantially Equivalent
K924011ORIGIN BLUNT TIP SURGICAL TROCARGCJSubstantially Equivalent
K922094DISSECTION INSTRUMENTGCJSubstantially Equivalent
K921040ENDOSCOPEGCJSubstantially Equivalent
K922751ORIGIN FLEXIBLE PORTGCJSubstantially Equivalent
K922460ORIGIN SECONDARY CANNULA AND TROCARGEASubstantially Equivalent
K920599HOOK SURGICAL INSTRUMENTGCJSubstantially Equivalent
K915116TROCAR SHEATH ANCHORHETSubstantially Equivalent
K913816ORIGINEEDLE, MODIFICATIONFHOSubstantially Equivalent
K914203LAPAROSCOPIC BALLOON RETRACTORGCJSubstantially Equivalent
K904848PORT-OF-ORGIN(TM) SINGLE-USE TROCAR AND SLEEVEHETSubstantially Equivalent
K904849ORIGINEEDLE(TM)FHOSubstantially Equivalent
K904156ORIGIN(TM) CEMENT EXTRACT SYST STD-PR/SPL-PR KITSLZVSubstantially Equivalent
K904180PROSTHETIC CEMENT REMOVERLZVSubstantially Equivalent
K890989DR. HERZBERG DISPOSABLE EXTERNAL FIXATORKTTSubstantially Equivalent for Some Indications
K896584ARTHROSCOPIC TUBING SHEATHHRXSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain