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FDA 510(k)

THE GRIPPER SEAL(TM)

K-Number: K870900 · 1987-03-31

ApplicantPharmacia Deltec, Inc.
Decision Date1987-03-31
Product CodeKGX
Advisory CommitteeHO
DecisionSubstantially Equivalent for Some Indications

Device Summary

THE GRIPPER SEAL(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Pharmacia Deltec, Inc.. It received FDA 510(k) clearance on 1987-03-31 under 510(k) number K870900. The device is classified under product code KGX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the THE GRIPPER SEAL(TM)?

THE GRIPPER SEAL(TM) is a medical device that received FDA 510(k) clearance on 1987-03-31. The listed applicant is Pharmacia Deltec, Inc.. The 510(k) number is K870900.

When did THE GRIPPER SEAL(TM) receive FDA 510(k) clearance?

THE GRIPPER SEAL(TM) received FDA 510(k) clearance on 1987-03-31, under 510(k) number K870900.

Who is the listed applicant for THE GRIPPER SEAL(TM)?

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

What is the FDA product code for THE GRIPPER SEAL(TM)?

The FDA product code for THE GRIPPER SEAL(TM) is KGX.

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Other records listing Pharmacia Deltec, 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.

K943310MODEL 6100 AMBULATORY INFUSION SYSTEMK942046PHARMACIA DELTEC EXTENSION SET WITH ANTI-SIPHON VALVEK942161LOCKBOXK942024PORT-A-CATH LOW PROFILE IMPLANTABLE VENOUS ACCESS SYSTEMK941445EXTENSION SET WITH ANTI-SIPHON VALVEK931073CATH-FINDER

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Related Devices (Code: KGX)

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.

K001240SERAGARD INJECTION PATCHPlatinum Services, Inc.K983368CARE BAND ANTIBACTERIAL BANDAGESAso Corp.K972914SYVEK PATCHMarine Polymer Technologies, Inc.K943314ADHESIVE BANDAGES WITH OTC DRUGJohnson & Johnson Consumer Products, Inc.K952606TARGETT PATCHCutting Edge Technologies, Inc.K954007PARALLELJohnson & Johnson Consumer Products, Inc.

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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