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FDA 510(k)

XP1100 RF

K-Number: K152731 · 2016-07-20

ApplicantBTL Industries, Inc.
Decision Date2016-07-20
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

XP1100 RF is the device name listed in this FDA 510(k) record. The listed applicant is BTL Industries, Inc.. It received FDA 510(k) clearance on 2016-07-20 under 510(k) number K152731. 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 XP1100 RF?

XP1100 RF is a medical device that received FDA 510(k) clearance on 2016-07-20. The listed applicant is BTL Industries, Inc.. The 510(k) number is K152731.

When did XP1100 RF receive FDA 510(k) clearance?

XP1100 RF received FDA 510(k) clearance on 2016-07-20, under 510(k) number K152731.

Who is the listed applicant for XP1100 RF?

The FDA 510(k) record lists BTL Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XP1100 RF?

The FDA product code for XP1100 RF is GEI.

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Other records listing BTL Industries, Inc. 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.

K252963BTL-899TTK253750BTL-785NEHK252561BTL-754FFK250309BTL-199K243290BTL-785MJK241516BTL-398

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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.

K261179AlphaTriPart - Monopolar MIC InstrumentsGimmi GmbHK253504Volnewmer™Classys, Inc.K254056THUNDERBEAT 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)Olympus Medical Systems Corp.K253484LUTRONIC GENIUSCynosure Lutronic Technology CorporationK251492Irrigation Tubing Bipolar Cord SetNew Deantronics Taiwan , Ltd.K260636Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingStryker Sustainability Solutions

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.

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