Data / Medical devices / United States / Intersurgical Inc.
Intersurgical Inc.: FDA-registered device maker in Indianapolis, IN, United States, 12 510(k) clearances
Intersurgical Inc. is registered with the FDA (registration 1832562) in Indianapolis, IN, United States. It lists 22 device types. The FDA files 12 510(k) clearances under its listings, the newest dated January 28, 2010. 1 recall event names it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1832562
- Address
- 2055 Executive Dr, Indianapolis, IN, United States, 46241
- Owner or operator
- Intersurgical Incorporated (9022693)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- November 27, 2002
- Registered through
- 2027
- Brand names listed
- 11386100, 14356000, 15146000, 15156000, 15166000, 15176000, 15416500, 15606500, 19416500, 19426500, 2010235, 2010261, 2158009, 2900077, 2900078, 2902022, 2902023, 21516000, 21586000, 29026000, 29006000, 21536000, 72946000, 72966000, 72936000, 72956000, 72966000 and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 28, 2010 | K091794 | CARE2 MEDICAL NEBULIZER, MODEL 101/102, 201/202 | CAF | Substantially Equivalent | Steve Islava | accessdata.fda.gov |
| May 9, 2008 | K080256 | PULMODYNE CHF FLOW GENERATOR SYSTEM | BYE | Substantially Equivalent | Pulmodyne | accessdata.fda.gov |
| June 21, 2007 | K070596 | TOPICAL APPLICATOR | CCT | Substantially Equivalent | Sharn, Inc. | accessdata.fda.gov |
| December 1, 2003 | K023683 | MULTI-STRAP FULL FACE MASK | BZD | Substantially Equivalent | Engineered Medical Systems | accessdata.fda.gov |
| April 19, 2002 | K013122 | EMS ELECTROSTATIC FLITER AND HME COMBINATION | CAH | Substantially Equivalent | Engineered Medical Systems | accessdata.fda.gov |
| March 14, 2002 | K013123 | EMS PULMONARY FUNCTION TESTING FILTER | BZG | Substantially Equivalent | Engineered Medical Systems | accessdata.fda.gov |
| November 30, 2000 | K003497 | DISPOSABLE PRESSURE MONITOR | CAP | Substantially Equivalent | Engineered Medical Systems | accessdata.fda.gov |
| January 22, 1999 | K983920 | EMS PEEP VALVES- ADJUSTABLE | BYE | Substantially Equivalent | Engineered Medical Systems | accessdata.fda.gov |
| January 28, 1998 | K972605 | EMS NASAL CPAP MASK | BZD | Substantially Equivalent | Engineered Medical Systems | accessdata.fda.gov |
| April 6, 1993 | K924610 | BAXTER ADULT/PEDI/INFANT SINGLE USE MAN RESUSCIT | BTM | Substantially Equivalent | Engineered Medical Systems | accessdata.fda.gov |
| October 23, 1991 | K913014 | EMS PERCUSSOR | BYI | Substantially Equivalent | Engineered Medical Systems | accessdata.fda.gov |
| March 29, 1983 | K830509 | EMERGENCY TRACHEOSTOMY & CRICOTHYROIDO- | BTO | Substantially Equivalent | Frederic J. Toye, M.D. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 12, 2011 | 64751 | Class I | Terminated | Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory and anesthesia applications as a conduit for various gases to resuscitate or to enhance breathing abilities of the patient.. | The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates. | accessdata.fda.gov |
Compare with other makers
- All makers of Mask, Gas, Anesthetic
- All makers of Applicator (Laryngo-Tracheal), Topical Anesthesia
- All makers of Ventilator, Non-Continuous (Respirator)
- All makers of Tube, Tracheostomy (W/Wo Connector)
- All makers of Strap, Head, Gas Mask
- All makers of Circuit, Breathing (W Connector, Adaptor, Y Piece)
Updated April 10, 2013. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.