Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1319447

FEI Number

1000120301

Entity Name

INTERSURGICAL, INC.

City/State/Country

East Syracuse, NY, US

Establishment Address

5010 Campuswood Dr, Ste 102, East Syracuse, NY 13057, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

INTERSURGICAL, INC. (Owner Number: 9002725)

Owner / Operator Contact Address

5010 Campuswood Dr, Ste 102, --, East Syracuse, NY 13057, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

StarMed Measuring Tape, CPMT6000 91236000, 21536500 14356000, Nose Clip-foam pads Silente, EcoLite, pediatric venturi mask, 11386100 93716000 8006007 Solus Flexible laryngeal mask airway with AccuCuff, 8001007, 8015007, 8002007, 8025007, 8003007, 8004007, 8005007 Solus Flexible laryngeal mask airway, 8001006, 8015006, 8002006, 8025006, 8003006, 8004006, 8005006, 8006006 Solus Laryngeal Mask, 8001032, 8002032, 8003032, 8004032, 8005032, 8015032, 8025032 8006005 Solus Silicone laryngeal mask airway with AccuCuff, 8001005, 8015005, 8002005, 8025005, 8003005, 8004005, 8005005 Solus Silicone laryngeal mask airway, 8015004, 8002004, 8025004, 8003004, 8004004, 8005004, 8006004 21556000, 29036000, 29026000, B0031001, 29006000, 29016000 21416000, 21516000 11426100 Earplugs, CP9086000 CP9036000

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2022-12-05
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2004-09-10
BXJ	Clip, Nose	Anesthesiology	Class 1	868.6225	2022-06-01
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	1997-08-04
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2019-04-04
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	1996-12-10
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	1996-12-10
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2013-02-06
EWD	Protector, Hearing (Insert)	Unknown	Class U	N/A	2022-12-02
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	2020-09-24

Official Correspondent

Kerrie Campbell

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

INTERSURGICAL, 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
K142467	Abeon Medical Corporation	IntelAir Nasal Airway Support System	2014-11-24
K861213	Datex Division Instrumentarium Corp.	PB 254 IR - SPECTROMETER	1986-04-04
K172904	Philips Medizin Systeme Boeblingen GmbH	IntelliVue Capnography Extension, IntelliVue Microstream Extension	2017-12-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0021-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N, Part Number CS08651-01
Z-0024-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657
Z-0025-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02
Z-0026-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01
Z-0027-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03

Similar Registrations

Registration Number	Establishment Name	Location
3007031057	MERCIAN SURGICAL SUPPLY CO LTD	Bromsgrove Worcestershire, GB
3011693567	LAMINATE MEDICAL TECHNOLOGIES	Tel Aviv, IL
3009134882	DMED	Seongnam-si Gyeonggi, KR
1057425	SOUTHEASTERN TECHNOLOGY dba Autocam Medical	Murfreesboro, TN, US
8044098	HGR INSTRUMENTE GMBH	TUTTLINGEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1319447. Last updated year: 2026. Please use registration number 1319447 when referencing this establishment in official correspondence.