Pivot International

FDA Device Registration & Listing · Lenexa, KS, US · Registration 1000655158

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1000655158
FEI Number
1000655158
Entity Name
Pivot International
City/State/Country
Lenexa, KS, US
Establishment Address
11030 Strang Line Rd, Lenexa, KS 66215, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Pivot International Inc (Owner Number: 10043496)
Owner / Operator Contact Address
11030 Strang Line Rd., Lenexa, KS 66215, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

BioWave GO Rx ASP-PUMP-120, PAL Aspiration Pump, 115V ASP-PUMP-240, PAL Aspiration Pump, 230V ASP-UI, PAL Aspiration Pump Console WalterLorenz Surgical Assist Arm

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Neurology Class 2 882.5890 2023-02-02
QPB System, Suction, Lipoplasty For Removal General, Plastic Surgery Class 2 878.5040 2025-07-02
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2013-02-21
GEY Motor, Surgical Instrument, Ac-Powered General, Plastic Surgery Class 1 878.4820 2013-02-21
FWZ Operating Room Accessories Table Tray General, Plastic Surgery Class 1 878.4950 2018-07-19

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Pivot International Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K122948 Gemore Technology Co, Ltd. GEM-STIM COMBO STIMULATOR 2012-12-21
K033455 Biomedical Life Systems, Inc. ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5 2004-01-15
K810593 Medical Devices, Inc. NEUROPAC ULTRA I 1981-03-13
K905383 Micro Surgical Instruments Corp. 2710-000 OSCILLATING SAW, GENERAL ASSEMBLY 1991-06-18
K913369 Micro Surgical Instruments Corp. MICRO-AIRE MODEL 2060 1991-11-01

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000655158. Last updated year: 2026. Please use registration number 1000655158 when referencing this establishment in official correspondence.
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