Data / Medical devices / India / Allwin Medical Devices Pvt. Ltd.

Allwin Medical Devices Pvt. Ltd.: FDA-registered device maker in Surat Gujarat, India, 6 510(k) clearances

Name: Allwin Medical Devices Pvt. Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Allwin Medical Devices Pvt. Ltd. is registered with the FDA (registration 9617744) in Surat Gujarat, India. It lists 29 device types. The FDA files 6 510(k) clearances under its listings, the newest dated October 13, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9617744
FEI number: 3006279007
Address: Plot No. 223, 230, and 221 Surat Special Economic Zone, Sachin, Surat Gujarat, India, 394230
Owner or operator: Allwin Medical Devices (9036357)
Roles: Manufacturer
First device listed: July 31, 2007
Registered through: 2026
Brand names listed: ASEPTO Bulb Irrigation Syringe, Amplatz Renal Dilator Set, Amplatz Sheath, Aspi Hydrophobic Filter Set - ASP-HFS, Aspi Suction Bottle with Connector - ASP-SB, Aspi Suction Line with Luer Lock Connectors - ASP - SL, AspiPump 90D - ASPI-90D, AspiPump Foot Switch - ASP - FS and more

Devices it lists

Device	Product code	Class	Role	Source
Adaptor, Bulbs, Miscellaneous, For Endoscope	FFY	1	Manufacturer	accessdata.fda.gov
Apparatus, Suction, Operating-Room, Wall Vacuum Powered	GCX	2	Manufacturer	accessdata.fda.gov
Cannula, Intrauterine Insemination	MFD	2	Manufacturer	accessdata.fda.gov
Catheter, Assisted Reproduction	MQF	2	Manufacturer	accessdata.fda.gov
Catheter, Nephrostomy, General & Plastic Surgery	GBO	1	Manufacturer	accessdata.fda.gov
Catheter, Urological	KOD	2	Manufacturer	accessdata.fda.gov
Clamp, Penile	FHA	1	Manufacturer	accessdata.fda.gov
Collector, Urine, (And Accessories) For Indwelling Catheter	KNX	2	Manufacturer	accessdata.fda.gov
Device, Intravascular Catheter Securement	KMK	1	Manufacturer	accessdata.fda.gov
Device, Percutaneous, Biopsy	MJG	1	Manufacturer	accessdata.fda.gov
Dilator, Catheter	GCC	1	Manufacturer	accessdata.fda.gov
Dilator, Cervical, Fixed Size	HDQ	1	Manufacturer	accessdata.fda.gov
Dilator, Urethral	KOE	2	Manufacturer	accessdata.fda.gov
Dislodger, Stone, Basket, Ureteral, Metal	FFL	2	Manufacturer	accessdata.fda.gov
Endoscopic Bite Block	MNK	1	Manufacturer	accessdata.fda.gov
Evacuator, Gastro-Urology	KQT	2	Manufacturer	accessdata.fda.gov
Forceps	HTD	1	Manufacturer	accessdata.fda.gov
Forceps, Biopsy, Non-Electric	FCL	1	Manufacturer	accessdata.fda.gov
Labware, Assisted Reproduction	MQK	2	Manufacturer	accessdata.fda.gov
Ligator, Hemorrhoidal	FHN	2	Manufacturer	accessdata.fda.gov
Lithotriptor, Biliary Mechanical	LQC	2	Manufacturer	accessdata.fda.gov
Needle, Aspiration And Injection, Disposable	GAA	1	Manufacturer	accessdata.fda.gov
Needle, Assisted Reproduction	MQE	2	Manufacturer	accessdata.fda.gov
Needle, Biopsy, Cardiovascular	DWO	1	Manufacturer	accessdata.fda.gov
Needle, Tumor Localization	MIJ	1	Manufacturer	accessdata.fda.gov
Stent, Ureteral	FAD	2	Manufacturer	accessdata.fda.gov
Stylet For Catheter, Gastro-Urology	EZB	1	Manufacturer	accessdata.fda.gov
Syringe, Irrigating (Non Dental)	KYZ	1	Manufacturer	accessdata.fda.gov
Trocar, Gastro-Urology	FBQ	2	Manufacturer	accessdata.fda.gov

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
October 13, 2022	K220730	allFlex Ureteral Catheters, Krait Ureteral Catheters	KOD	Substantially Equivalent	Allwin Medical Devices, Inc.	accessdata.fda.gov
June 4, 2021	K203626	SureStrip Vitrification Straw, SureLock Vitrification Straw	MQK	Substantially Equivalent	Allwin Medical Devices, Inc.	accessdata.fda.gov
July 1, 2020	K200248	Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators	MQF	Substantially Equivalent	Allwin Medical Devices, Inc.	accessdata.fda.gov
December 2, 2019	K190659	Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatric Ureteral Stent Open Tip/Closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/Closed Tip, Multiloop Ureteral Stent Open Tip/Closed Tip	FAD	Unknown	Allwin Medical Devices, Inc.	accessdata.fda.gov
November 25, 2019	K190590	Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle)	MQE	Substantially Equivalent	Allwin Medical Devices, Inc.	accessdata.fda.gov
November 14, 2019	K190522	Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED and CURVED Open Tip Intra Uterine Insemination Catheter, TRACKABLE and TRACKABLE Open Tip Intra Uterine Insemination Catheter, FLEXI and FLEXI Open Tip Intra Uterine Insemination Catheter, STUMPY Intra Uterine Insemination Catheter)	MQF	Substantially Equivalent	Allwin Medical Devices, Inc.	accessdata.fda.gov

Compare with other makers

Updated October 13, 2022. 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.