United Surgical LLC
Laotto, IN, US
UNITED SURGICAL LLC appears in FDA device records in Laotto, IN. FDA records list 7 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to United Surgical LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- United Surgical Associatesenforcement report, recall
510(k) clearance history
FDA records hold 7 510(k) clearances for United Surgical LLC between 1983 and 1990. The busiest year on record is 1987, with 4. The most recent is 1990, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 1 |
| 1986 | 1 |
| 1987 | 4 |
| 1990 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K902150 | PIEZO HANDPIECE | HQC | Substantially Equivalent | |
| K870671 | PHACOTRON DAY PAK | HQC | Substantially Equivalent | |
| K870806 | NON-STERILE, EXTRA PLUS PAK CAT. #USPK 2100 | HQC | Substantially Equivalent | |
| K870195 | UNITED SURGICAL CORP. CRYOPTIC PLUS | HPS | Substantially Equivalent | |
| K870194 | UNITED SURGICAL CORP. DIATHERMIC PLUS | HQR | Substantially Equivalent | |
| K860014 | SYSTEMS PLUS | HQE | Substantially Equivalent | |
| K830741 | PARAMETRIC STERILITY RELEASE OF AUTO | GAG | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2087423 | 3003707831 | UNITED SURGICAL LLC | 11654 E 400 S, Laotto, IN 46763 US | 2026 | |
| 3006619688 | 3006619688 | UNITED SURGICAL, LTD. | 93, ISLAMPUR, P.U. KADDA, GAZIPUR GA 21 PUR BD | 2026 | and 4 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- ILSAdaptor, Hygiene
- IKXAid, Transfer
- HQRApparatus, Cautery, Radiofrequency, Ac-Powered
- INBAttachment, Commode, Wheelchair
- FSDBinder, Abdominal
- IPRCrutch
- HQEInstrument, Vitreous Aspiration And Cutting, Ac-Powered
- ITWJoint, Ankle, External Brace
- ITQJoint, Knee, External Brace
- FSALift, Patient, Non-Ac-Powered
- IQKOrthosis, Cervical
- IQIOrthosis, Limb Brace
- IQEOrthosis, Lumbar
- FMQRestraint, Protective
- IPGShoe, Cast
- ILISling, Arm
- ILHSplint, Hand, And Components
- GAGStapler, Surgical
- IOYSupport, Arm
- HPSUnit, Cryophthalmic
- HQCUnit, Phacofragmentation
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1666-2015 | Keo Brace, elastic wrist brace for carpal tunnel. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. | The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction | Class II | Terminated | |
| Z-1665-2015 | Elastic Knee Support. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. | The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction | Class II | Terminated | |
| Z-1664-2015 | Elastic Ankle Support. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. | The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain